Class II
Medical Device Recall: Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
Cardinal Health 200, LLC · November 8, 2024
Reason for Recall
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
States Affected
NATIONWIDE
Quantity Affected
512,786 total units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0911-2025
Status: ongoing
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